VIKAAIR

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VICAIR® (VICAIR)

Composition:

Active substances: 1 tablet contains basic bismuth nitrate, calculated as 282 mg of bismuth oxide – 350 mg, heavy magnesium carbonate, calculated as 168.5 mg of magnesium oxide – 400 mg, sodium bicarbonate – 200 mg, powdered cascara bark – 25 mg, powdered calamus rhizomes – 25 mg;

Excipients: magnesium stearate, potato starch, talc.

Pharmaceutical form. Tablets.

Main physico-chemical properties: tablets from pink-brown to pink-purple in color with white and dark specks, oval-shaped with a biconvex surface, with a score line on one side of the tablet.

Pharmacotherapeutic group. Drugs for treatment of peptic ulcer and gastro-esophageal reflux disease. ATC code A02BX.

Pharmacological properties.

Pharmacodynamics.

Vikair® exerts a complex action. Bismuth nitrate basic, sodium bicarbonate, and heavy magnesium carbonate exert an antacid and astringent effects, buckthorn bark produces a laxative effect, and sweet flag rhizome has a spasmolytic effect.

Pharmacokinetics. Data are lacking.

Clinical characteristics.

Indications.

As part of complex therapy for gastric and duodenal peptic ulcer, functional dyspepsia, hyperacid gastritis.

Contraindications.

Hypersensitivity to the components of the drug. Chronic and inflammatory intestinal and gallbladder disorders; hypacid gastritis; gastrointestinal bleeding; severe renal function impairment; acute typhoid states.

Cascara bark: neurogenic and endocrine constipation, spastic constipation, intestinal obstruction, hemorrhages, acute abdomen syndrome, appendicitis, acute gastroenterocolitis.

Special precautions.

During treatment, a special diet should be followed.

Renal function and bismuth concentration in blood and urine should be monitored during therapy. Stool may turn dark green or black during tablet intake.

The drug should be taken 2 hours before or after the administration of other medicinal agents.

Interaction with other medicinal products and other types of interactions.

The resorptive effect of tetracyclines is reduced when used concomitantly, because complexes poorly absorbed in the gastrointestinal tract are formed due to interaction between tetracyclines and medicinal products containing magnesium cations.

During treatment with Vikair®, other bismuth-containing drugs should not be taken to avoid the risk of increased bismuth concentration in blood.

Concomitant use with alkaloids, glycosides, enzyme preparations, and antibiotics is not recommended.

The drug reduces absorption of coumarin derivatives.

Reduced absorption of other medicinal products taken concomitantly with Vikair® is possible. Therefore, the interval between administration of these drugs should be at least 2 hours.

Special precautions for use.

Antacid medications and milk should not be taken within half an hour before or half an hour after taking the drug, since gastric juice is required for the formation of the protective layer.

Prolonged use of bismuth-containing compounds is not recommended due to the rare occurrence of encephalopathy. When following the recommended dosing regimen, the risk of this adverse effect is very low; however, during treatment with this drug, concomitant use of other bismuth-containing medications is not recommended.

Use during pregnancy or breastfeeding. Vikair® should not be used during pregnancy. During breastfeeding, use of the drug must be discontinued.

Ability to affect reaction speed when driving or operating machinery. Currently, there is no information indicating an adverse effect on reaction speed while driving or operating machinery.

Method of Administration and Dosage.

Vikair® should be taken orally after meals.

Take 1-2 tablets three times daily, washed down with ½ glass of warm water (it is advisable to crush the tablets beforehand).

The treatment duration is determined by the physician depending on the nature and severity of the disease.

Children. There is no experience with use in children.

Overdose. Symptoms: nausea, vomiting, diarrhea.

Treatment: symptomatic.

Bismuth.

With frequent administration of high doses of the drug, bismuth overdose is possible, which may manifest after 10 days with symptoms characteristic of renal failure (increased bismuth level in blood plasma).

Cascara bark.

Symptoms: colicky abdominal pain, tenesmus, discomfort.

Adverse reactions.

Gastrointestinal system: increased defecation, which resolves upon dose reduction; nausea, vomiting, tongue pigmentation.

Central nervous system: headache.

Blood and lymphatic system: hemoglobinemia.

General disorders: gingival and eyelid edema.

Other: allergic reactions, including urticaria, rash, pruritus, and swelling.

Bismuth.

Skin and subcutaneous tissue: rash, pruritus.

Gastrointestinal system: black or dark green discoloration of stools.

Cortex frangulae (buckthorn bark).

Gastrointestinal system: dehydration, reduced intestinal enzyme function, colon atony, colicky pain.

Rhizoma lepichis (lepechitsa rhizome).

Immune system: urticaria, skin rash, pruritus, swelling.

Shelf life. 5 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. Tablets: 10 in a strip; 10 in a blister; 10 in a blister, 2 blisters in a carton; 10 in a blister, 1 blister in a carton.

Dispensing category. Over-the-counter.

Manufacturer.

1. JSC "Kyivmedpreparat".
2. JSC "Halychpharm".

Manufacturer's address and location of business activity.

1. 139 Saksaganskoho Street, Kyiv, 01032, Ukraine.
2. 6/8 Opryshkovska Street, Lviv, 79024, Ukraine.

Marketing authorization holder.

JSC "Halychpharm".

Address of the marketing authorization holder.

6/8 Opryshkovska Street, Lviv, 79024, Ukraine.